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Effects of Spironolactone on Cardio- and Cerebrovascular Morbidity and Mortality in Hemodialysis Patients

Primary Purpose

End-stage Renal Failure

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Spironolactone
Sponsored by
Dialysis Outcomes Heart Failure Aldactone Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for End-stage Renal Failure focused on measuring cardiovascular event, hemodialysis, spironolactone

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Hemodialysis patients undergoing 4-hour-long HD thrice a week for at least 2 years
  • With an average serum potassium level (immediately before dialysis on the first day of the week) of <6.5 mEq/l over the previous 2 months
  • With a 24-hour urine output of <500 ml

Exclusion Criteria:

  • A history of noncompliance
  • Unstable vascular access
  • Hypotension
  • Hepatic failure
  • Active cancer
  • Any life-threatening disease other than ESRD

Sites / Locations

  • Shibukawa Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

spironolactone

Arm Description

Outcomes

Primary Outcome Measures

cardio- and cerebrovascular events

Secondary Outcome Measures

death from all causes

Full Information

First Posted
September 12, 2012
Last Updated
September 14, 2012
Sponsor
Dialysis Outcomes Heart Failure Aldactone Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT01687699
Brief Title
Effects of Spironolactone on Cardio- and Cerebrovascular Morbidity and Mortality in Hemodialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dialysis Outcomes Heart Failure Aldactone Study Group

4. Oversight

5. Study Description

Brief Summary
Aldosterone receptor blockers reduce cardiac-related morbidity and mortality. Recently, we demonstrated that long-term low-dose spironolactone is clinically safe in many hemodialysis (HD) patients. In the present study, we assess whether low-dose spironolactone treatment reduces the high incidence of cardio- and cerebrovascular (CCV) morbidity and mortality in HD patients. The investigators' hypothesis is that aldosterone receptor blockade by spironolactone reduces the risk of both CCV morbidity and death among HD patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Failure
Keywords
cardiovascular event, hemodialysis, spironolactone

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
spironolactone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Primary Outcome Measure Information:
Title
cardio- and cerebrovascular events
Secondary Outcome Measure Information:
Title
death from all causes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Eligibility Criteria
Inclusion Criteria: Hemodialysis patients undergoing 4-hour-long HD thrice a week for at least 2 years With an average serum potassium level (immediately before dialysis on the first day of the week) of <6.5 mEq/l over the previous 2 months With a 24-hour urine output of <500 ml Exclusion Criteria: A history of noncompliance Unstable vascular access Hypotension Hepatic failure Active cancer Any life-threatening disease other than ESRD
Facility Information:
Facility Name
Shibukawa Clinic
City
Shizuoka
ZIP/Postal Code
424-0053
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
33586138
Citation
Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.
Results Reference
derived
PubMed Identifier
24184249
Citation
Matsumoto Y, Mori Y, Kageyama S, Arihara K, Sugiyama T, Ohmura H, Yakushigawa T, Sugiyama H, Shimada Y, Nojima Y, Shio N. Spironolactone reduces cardiovascular and cerebrovascular morbidity and mortality in hemodialysis patients. J Am Coll Cardiol. 2014 Feb 18;63(6):528-36. doi: 10.1016/j.jacc.2013.09.056. Epub 2013 Oct 30.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/19342857
Description
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Learn more about this trial

Effects of Spironolactone on Cardio- and Cerebrovascular Morbidity and Mortality in Hemodialysis Patients

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